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Dry EyeNCT03265652

IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD

A study testing Intense Pulsed Light (IPL) therapy in people with Dry Eye and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye, Meibomian Gland Dysfunction
What is being tested?
Intense Pulsed Light (IPL) therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteIsrael
Study dates
15 May 2018to 18 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is able to read, understand and sign an Informed Consent (IC) form
  • Subject is 18 years or older
  • Subject has Fitzpatrick skin type I to IV
  • SPEED questionnaire equal or more than 10
  • OSDI questionnaire equal or more than 23
  • In both eyes, at least 5 non-atrophied meibomian glands on the lower eyelid.
  • In both eyes, Tear break up time equal or less than 7 seconds
  • In both eyes, MGA (the total meibomian gland score for 15 glands of the lower eyelid) is smaller or equal to 12

Who cannot join

  • Contact lens wear within the month prior to screening
  • Unwilling to discontinue use of contact lenses for the duration of the study
  • Ocular surgery or eyelid surgery within 6 months prior to screening
  • Neuro-paralysis in the planned treatment area within 6 months prior to screening
  • Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
  • Current use of punctal plugs
Show all 25Show fewer
  • Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
  • Uncontrolled infections or uncontrolled immunosuppressive diseases
  • Subjects with ocular infections within 6 months prior to screening
  • Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm (e.g., Herpes simplex 1 \& 2, Systemic Lupus erythematosus, porphyria)
  • Use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, such as Isotretinoin, Tetracycline, Doxycycline, or St. John's Wort within 3 months prior to screening
  • Over exposure to sun within 4 weeks prior to screening, in the judgment of the investigator
  • Administration of prescription eye drops for dry eye within 7 days prior to screening, excluding artificial tears and glaucoma drops
  • Radiation therapy to the head or neck within 12 months prior to screening, or planned radiation therapy within 8 weeks after completion of all IPL treatments
  • Treatment with chemotherapeutic agent within 8 weeks prior to screening, or planned chemotherapy within 8 weeks after completion of all IPL treatments
  • New topical treatments within the area to be treated, or oral therapies within 3 months prior to screening, except over-the-counter acetaminophen-based analgesics (such as Extra Strength Tylenol®) for pain management after study treatment, new oral omega 3 fatty acid supplements and topical artificial tears
  • Change in dosage of any systemic medication within 3 months prior to screening
  • Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
  • Legally blind in either or both eyes
  • History of migraines, seizures or epilepsy
  • IPL treatment within 12 months prior to screening
  • Lipiflow treatment, or any other thermal treatment of the eyelids, within 6 months prior to screening
  • Expression of the meibomian glands within 6 months prior to screening
  • Any condition revealed during the eligibility screening process whereby the investigator deems the subject inappropriate for this study
  • Women below the age of menopause (50 years of age)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Shaare Zedek

    Jerusalem

Other trials in Israel

About this study

Official title: Intense Pulsed Light and Meibomian Gland Expression (MGX) Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to Meibomian Gland Dysfunction

The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland dysfunction. The effect of IPL will be examined in a study designed as a randomized controlled trial. In the study arm, subjects will undergo 4 treatment sessions, consisting of IPL pulses immediately followed by expression of the meibomian glands. In the control arm, subjects will undergo the same treatments, except that the IPL pulses will be disabled. For each subject, the duration of the study will be 10 weeks, as explained in the detailed description,

Read the detailed description

Outcome measures (tear break-up time, tear film osmolarity, meibomian gland assessment, number of meibomian glands yielding liquid secretion in lower eyelid , meibography, self-assessed symptoms and close up photos of the lid margins) will be measured at baseline. All subjects will receive 4 treatments at 2 weeks intervals. In each treatment session, a subject allocated to the study group will be treated with IPL administered in the malar region, from tragus to tragus including the nose, 2-3 mm below the lower eyelids. Immediately following the IPL administration, the meibomian glands will be manually expressed from both eyelids. Subjects in the control arm will receive exactly the same treatment, except that the IPL administration will be sham. A single follow-up will occur at 10 weeks after the baseline (or 4 weeks after the 4th treatment session). At the follow-up, the changes in the outcome measures will be evaluated, and compared between the two arms.

For each subject, the duration of the study will be 10 weeks: 1st treatment at baseline; 2nd treatment at 2 weeks after baseline; 3rd treatment at 4 weeks after baseline; 4th treatment at 6 weeks after baseline; and a single follow-up at 10 weeks after baseline).

Statistically significant differences between the two arms will support the study hypothesis that IPL treatment itself provides relief to both signs and symptoms of dry eye disease.

Being tested
Intense Pulsed Light (IPL) therapy, Sham therapy
Keywords
Intense Pulsed Light, Meibomian Gland Dysfunction, Dry Eye Disease
Medical subject headings
Dry Eye Syndromes, Meibomian Gland Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intense Pulsed Light (IPL) therapyDevice

    Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

  • Sham therapyDevice

    Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.

Study groups in NCT03265652
Study groupRoleWhat they receive
Intense Pulsed Light (IPL) therapyExperimentalSubjects with receive 10-15 intense pulsed light (IPL) pulses on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid. Following the administration of IPL pulses, subjects will undergo meibomian gland expression.
Receives: Device: Intense Pulsed Light (IPL) therapy
Sham therapyPlacebo comparatorParticipants will undergo a sham treatment that will mimic the intense pulsed light (IPL) therapy. The tip of the IPL lightguide will be placed in 10-15 locations on the skin of the malar region (both cheeks, from tragus to tragus including the nose) and up to 3 mm from the lid margin of the lower eyelid, but IPL pulses will not be actually delivered. Following this sham procedure, subjects will undergo meibomian gland expression.
Receives: Device: Sham therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of baseline TBUT

    Change of Tear break up time in the study eye, from baseline to follow-up

    Measured: 10 weeks

Secondary outcomes (2)

  1. Change from baseline MGA

    Change of Meibomian gland secretion score, from baseline to follow-up, in both eyes

    Measured: 10 weeks

  2. Change from baseline OSDI

    Change of self-assessed symptoms with the OSDI questionnaire, from baseline to follow-up, in both eyes

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start15 May 2018
  3. Primary completion18 Apr 2019
  4. Study completion18 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized 1:1 to a study arm and a control arm. Subjects in the study arm will be treated with IPL and meibomian gland expression. Subjects in the control arm will be treated with sham and meibomian gland expression.
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265652
Sponsor's protocol ID
LUM-VBU-IPL-M22-17-02
Other IDs
0171-17-SZMC
Status last verified
Feb 2020
First submitted
22 Aug 2017
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: At this point it is not yet decided if and how to share IPD with other researchers

Questions about this trial

What is this clinical trial studying?

A study testing Intense Pulsed Light (IPL) therapy in people with Dry Eye and Meibomian Gland Dysfunction, run by Lumenis Be Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of baseline TBUT (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03265652.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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